使用拉曼光谱和PLS来量化生物制药产品的关键质量属性
Ambra Massei1, Nunzia Falco2, Davide Fissore3
1Dipartimento di Scienza Applicata e Tecnologia, Politecnico di Torino, Corso Duca degli Abruzzi 24, Torino 10129, Italy; Global Parenteral Development, Merck Serono SpA, Via Luigi Einaudi 11, Guidonia Montecelio, Roma 00012, Italy.
Journal of pharmaceutical and biomedical analysis
|October 11, 2025
概括
拉曼光谱与部分最小平方 (PLS) 结合,有效量化生物制药的关键质量属性 (CQAs),如蛋白质聚合和组成. 这种过程分析技术 (PAT) 方法在开发过程中为监测产品质量提供了出色的性能.
科学领域:
- 制药科学 制药科学
- 分析化学 分析化学
- 生物技术是生物技术.
背景情况:
- 过程分析技术 (PAT) 为制药生产提供实时监控.
- 拉曼光谱和化学测量是理解过程的先进工具.
- 关键质量属性 (CQA) 要求对产品的安全性和有效性进行精确的量化.
研究的目的:
- 应用拉曼光谱和部分最小方程 (PLS) 来量化生物制药中的多个CQA.
- 评估这种PAT方法在监测蛋白质聚合,碎片化和组成方面的有效性.
- 用实时分析方法评估工艺参数对产品质量的影响.
主要方法:
- 使用拉曼光谱,一种非破坏性技术,用于光谱数据采集.
- 用的部分最小平方 (PLS) 化学测量建模用于定量分析.
- 在单克隆抗体模型中研究了蛋白质/辅助剂的量化,氧化,聚合 (HMW) 和碎片化 (LMW).
主要成果:
- 拉曼光谱和PLS的组合在量化高分子量 (HMW) 和低分子量 (LMW) 物种以及产品成分方面表现出色.
- 这种方法在这些CQA中显示出优异的结果,与传统的分析技术相比.
- 拉曼光谱在识别氧化水平方面遇到了局限性,可能是由于灵敏度或校准挑战.
结论:
- 拉曼光谱与PLS相结合,是一种强大的PAT工具,用于实时监测和量化关键生物制药CQA.
- 这种方法可以提高生物制药开发过程中的流程理解和控制.
- 拉曼光谱需要进一步优化,以准确量化蛋白质氧化水平.
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